Cloned biological material medical device and method thereof

ABSTRACT

A medical device, said medical device, comprises: a first component having a non-biological material; a second component having a cloned biological material, said second component being attached to said first component, wherein said first component and said second component are operatively associated in a non-living medical device for at least one of treatment, diagnosis, cure, mitigation and prevention of disease, injury, handicap or condition in a living organism. In another aspect, a method comprises: preparing a cloned biological material from a tissue or an organ; attaching said biological material to a medical device; interfacing said biological material with the non-biological material; providing treatment, diagnosis, cure, mitigation and prevention of disease, injury, handicap or condition in a living organism.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional application of U.S. application Ser.No. 13/044,591, filed Mar. 10, 2011, and entitled, A Cloned BiologicalMaterial Medical Device and Method Thereof.”

BACKGROUND

1. Field of Disclosure

The present invention relates generally to medical devices and methodfor reducing or preventing immune reactions and improving circuitry.

2. Related Art

The tissue-equivalents of Bell, U.S. Pat. No. 4,485,096, are livingprostheses comprising contracted hydrated lattices of tissue and cells,including cartilage, fibroblasts, keratinocytes, bone cells, pancreaticcells and heart muscle cells. The tissue-equivalents are formed assheets, tubes and other shapes in a mold. Naughton et al., U.S. Pat. No.5,863,531 is an in vitro preparation of tubular tissue structures bystromal cell culture on a three-dimensional framework. Stromal cells aregrown on a three-dimensional framework and formed into three-dimensionalliving stromal tissue of various shapes, including tubular structures,flat structures and rope structures. The method for the inhibition ofcompliment activation, set forth in Krumdieck et al., U.S. Pat. No.5,650,389 comprises coating biomaterial with proteogylcan to suppress orinhibit C 1 complex biological activity. The proteogylcan inhibit thecomplement response of a human or an animal to the foreign materialssuch as microorganisms, pathogens or biomaterials. A disadvantage ofprior inventions is that the cellular material or tissue is not used ona medical device or as part of machine. There exists a need for amedical device comprising cloned biological material operativelyassociated to a non-biological material in a non-living medical devicefor treatment, diagnosis, cure, litigation and prevention of disease,injury, handicap or condition in a living organism.

SUMMARY

A medical device, said medical device, comprising: a first componenthaving a non-biological material; a second component having a clonedbiological material, said second component being attached to said firstcomponent, wherein said first component and said second component areoperatively associated in a non-living medical device for at least oneof treatment, diagnosis, cure, mitigation and prevention of disease,injury, handicap or condition in a living organism.

In another aspect, a method comprising: preparing a cloned biologicalmaterial from a tissue or an organ; attaching said biological materialto a medical device; interfacing said biological material with thenon-biological material; providing treatment, diagnosis, cure,mitigation and prevention of disease, injury, handicap or condition in aliving organism.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates method comprising: preparing a cloned biologicalmaterial from a tissue or an organ, attaching the biological material toa medical device, interfacing the biological material with thenon-biological material for treatment, diagnosis, cure, mitigation andprevention of disease, injury, handicap or condition in a livingorganism.

FIG. 2A illustrates a method of preparing a cloned biological materialsuch as a shaped tissue structure from a tissue or organ of anindividual for use on a non-living medical device or as part of anon-living medical device for treatment, diagnosis, cure, mitigation andprevention of disease, injury, handicap or condition in a livingorganism.

FIG. 2B illustrates a method of preparing a cloned biological materialsuch as a shaped tissue structure from a connective tissue of a donorfor use on a medical device or as part of a non-living medical devicefor treatment, diagnosis, cure, mitigation and prevention of disease,injury, handicap or condition in a living organism.

FIG. 2C provides an example of a method of preparing a cloned biologicalmaterial such as a shaped tissue structure or a shaped organ structurefrom a tissue or an organ, further including genetically modifying cellsto express or inactivate the expression of a protein, an enzyme, or afactor for treatment, diagnosis, cure, mitigation and prevention ofdisease, injury, handicap or condition in a living organism.

FIG. 3 provides an example of a method of dissociating the cellularmaterial into a cell suspension using cell separation to obtain desiredcells, wherein cell separation is cloning and cell selection.

FIG. 4 illustrates a method of using a cloned biological material suchas a shaped tissue structure or shaped organ structure on a medicaldevice or as part of a medical device, including modifying or refiningthe shaped tissue structure or shaped organ structure.

FIG. 5 illustrates a method of using a cloned biological material suchas a shaped tissue structure or shaped organ structure on a medicaldevice or as part of a medical device, including the attachment of thecloned biological material on a medical device or as a part of themedical device.

FIG. 6 illustrates a medical device comprising a first component havingnon-biological material and second component having cloned biologicalmaterial attached and operatively associated in a non-living medicaldevice for treatment, diagnosis, cure, mitigation and prevention ofdisease, injury, handicap or condition in a living organism.

FIG. 7 illustrates a cloned biological material such a shaped tissuestructure grown from cloned cells for use as an enclosure on a catheterfor preventing immunological reaction.

FIG. 8 and FIG. 8A show simplified examples of cloned biologicalmaterial such as shaped tissue structures or shaped organ structures inthe form of a dialysis venous tube and a dialysis arterial tube for adialysis medical machine.

FIG. 8B illustrates an examples of cloned biological material such asshaped tissue structures or shaped organ structures in the form ofconnector tubes of a dialysis medical machine.

FIG. 9 illustrates a cloned biological material such as a shaped tissuestructure grown from cloned cells used as tubing on an annuloplasty bandfor preventing immunological reaction.

FIG. 10 illustrates cloned biological material such as a shaped tissuestructure grown from cloned cells as drug delivery tube on a drugdelivery device for preventing immunological reactions.

FIG. 10A illustrates a simplified example of a dialysis microchipdevice.

FIG. 11 illustrates a cloned biological material such as a shaped tissueor organ structure in the form of a screw in an end effector of arobotic surgical arm.

FIG. 12 and FIG. 12A illustrate examples of a cloned biological materialsuch as a shaped tissue structure or organ structure grown from clonedcells in the form of a bolt on a medical device or medical machine suchas an medical delivery pump for delivering drugs to a patient.

FIG. 13 and FIG. 13A illustrate examples of a cloned biological materialsuch as a shaped tissue structure or a shaped organ structure in theform of a gasket for a hemostatic valve.

FIG. 14 illustrates a cloned biological material such as a shaped tissuestructure grown from cloned cells for use on a pacemaker for treatment,diagnosis, cure, mitigation and prevention of disease, injury, handicapor condition in a living organism.

FIG. 15 illustrates a method of preparing a cloned biological materialsuch as a shaped tissue structure or a shaped organ structure from atissue or an organ including growing the desired cells on said medicaldevice to form the shape of the cloned biological material.

DETAILED DESCRIPTION

The present invention will be described in association with referencesto drawings; however, various implementations of the present inventionwill be apparent to those skilled in the art.

FIG. 1 illustrates a method comprising: preparing a cloned biologicalmaterial from a tissue or an organ in step 101, attaching a biologicalmaterial to a medical device in step 102, interfacing the biologicalmaterial with the non-biological material in step 103 and providingtreatment, diagnosis, cure, mitigation and prevention of disease,injury, handicap or condition in a living organism in step 104.

In one aspect, the method of preparing a cloned biological material(i.e., a shaped tissue structure or a shaped organ structure) from atissue or an organ includes removing a portion of the tissue or theorgan from an individual; isolating a cellular material from the portionof the tissue or the organ; dissociating the cellular material into acell suspension using cell separation to obtain desired cells; andgrowing the desired cells on a shaped matrix to form the clonedbiological material (i.e., shaped tissue structure or shaped organstructure). The method of removing a portion of a tissue or an organfrom an individual may include excising a portion of the tissue or theorgan. The method of isolating the cellular material from a portion ofthe tissue or the organ may include disaggregating cellular materialfrom the tissue with a digestive enzyme (i.e., trysin, chymotrysin,collagenase, elastase, hydraluronidase, DNase, pronase, disease) and/ortreating the tissue or organ with a chelating agent. The method ofdissociating the cellular material into a cell suspension using cellseparation to obtain desired cells may include cell separation bynegative separation, filtration, centrifugation, electrophoresis, unitgravity separation and/or cloning and cell selection.

For example, FIG. 2A illustrates a method of preparing a clonedbiological material (i.e., a shaped tissue structure or a shaped organstructure) from a tissue or organ of an individual for use on a medicaldevice or as part of the medical device for treatment, diagnosis, cure,mitigation and prevention of disease, injury, handicap or condition in aliving organism. Cellular material may be removed from the tissue ororgan of an individual in step 201 a. The tissue or organ may bedisaggregated to isolate cellular material in step 202 a of FIG. 2. Thetissue or organ may also be treated with a chelating agent for isolationof cellular material in step 203 a. The tissue or organ is dissociatedinto a cell suspension in step 204 a. In step 205 a, cell separationmethods (i.e., negative separation, filtration, centrifugation,electrophoresis, unit gravity separation and cloning and cell selection)may be used to obtain desired cells from the cell suspension. Thedesired cells are distributed on a shaped matrix in step 206 a. Thecells are grown on the shaped matrix (e.g., a tubular matrix,thread-like matrix, twisted rope matrix, flat matrix, sheet matrix,spherical matrix, rod matrix, cubical matrix and/or other shaped matrix)to form a cloned biological material (i.e., a shaped tissue structure ora shaped organ structure) in step 207 a. According to step 208 a, theshaped tissue structure may be used on a non-living medical device or aspart of a non-living medical device for providing treatment, diagnosis,cure, mitigation and prevention of disease, injury, handicap orcondition in a living organism.

An increased risk of thrombosis, clotting and hyperplasia may resultwhere medical devices, comprise artificial materials that comes incontact with the body. Medical devices, comprising autologous material,have been used to prevent or reduce the risk of thrombosis, clotting andhyperplasia. The tissue structures or organ structures of the presentinvention prevent the compliment activation of blood such as thecreation of microemboli, which occurs from contact with artificialmaterial of a medical device.

In another aspect of the present invention, the method of preparing acloned biological material (i.e., a shaped tissue structure or a shapedorgan structure) from a tissue or an organ includes removing a portionof a tissue or an organ from a donor; isolating a cellular material fromthe portion of the tissue or the organ; dissociating the cellularmaterial into a cell suspension using cell separation to obtain desiredcells; and growing the desired cells on a shaped matrix to form thecloned biological material (i.e., shaped tissue structure or shapedorgan structure). For example, FIG. 2B illustrates a method of preparinga cloned biological material (i.e., shaped tissue structure) from aconnective tissue of a donor. Cellular material may be removed from theconnective tissue of a donor in step 201 b of FIG. B. The cellularmaterial is isolated from the connective tissue of the donor in step 202b. The cellular material may be disaggregated from the connective tissueof the donor with a digestive enzyme (i.e., trysin, chymotrysin,collagenase, elastase, hydraluronidase, DNase, pronase, dispase) and/ortreating the tissue or organ with a chelating agent in step 202 b. Afterthe cellular material is isolated from the connective tissue of thedonor in step 201 b and the cellular material is dissociated into a cellsuspension in step 203 b, the desired cells (i.e., pericytes,adipoctyes, macrophages, monocytes, plasma cells, mast cells andendothelial cells) may be obtained using cell separation methods (i.e.,negative separation, filtration, centrifugation, electrophoresis, unitgravity separation and cloning and cell selection) in step 204 b. Thedesired cells are distributed on a matrix (e.g., a tubular matrix,thread-like matrix, twisted rope matrix, flat matrix, sheet matrix,spherical matrix, rod matrix, cubical matrix and/or other shaped matrix)in step 205 b. According to steps 206 b and 207 b, the desired cells aregrown on the shaped matrix for use on a non-living medical device or aspart of a non-living medical device for providing treatment, diagnosis,cure, mitigation and prevention of disease, injury, handicap orcondition in a living organism.

The method of preparing a cloned biological material (i.e., a shapedtissue structure or a shaped organ structure) from a tissue or an organmay further include genetically modifying cells to express or inactivatethe expression of proteins, enzymes, or factors for prevention orreduction of thrombosis, hyperplasia, inflammation, occlusion, andimmunological reactions. The cells may be genetically modified (e.g.,using ribozymes, vectors, endogenous cellular gene activation orrepression, small molecule regulation, over expression of cDNA clones,antisense, gene knock outs etc.) to alter gene expression. The vectors,comprising DNA segments may be introduced to cells via transfer methodssuch as transfection, transduction, calcium phosphate-mediatedtransformation, microinjection, electroporation or osmotic shock. Cellsmay be genetically modified to activate enzymes or factors orgenetically modified to inactivate the expression of enzymes or factorsfor prevention or reduction of thrombosis, hyperplasia, inflammation,occlusion, and other immunological reactions. For instance, the cellsmay be genetically modified to express anti-inflammatory peptides,proteins, or factors such as anti-GM-CSF, anti-TNF, anti-IL-1,anti-IL-2. Cells may be genetically modified to express anticoagulationgene products, which improve platelet aggregation and prevent ordecrease blood coagulation and thromoboembolism. The cells may begenetically modified for expression of enzymes, including streptokinase,tissue plasminogen activator and urokinase for clot reduction. The cellsmay be genetically modified to prevent or reduce hyperplasia by blockingexpression of antisense oligodeoxynucleotide. The cells may begenetically modified to inactivate gene expression via partial genedeletion or complete gene deletion.

The cells may be genetically modified to inactivate gene expression bypreventing production of messenger RNA (mRNA). Proteins are a product ofgene expression. A promoter is located upstream of genes on the DNA. RNApolymerase binds to the promoter of the DNA. As RNA polymerase travelsdown one strand of the DNA during transcription, RNA polymerase readsthe nucleotide base sequence of the DNA. RNA polymerase makes acomplementary strand of mRNA. A repressor protein, located downstream ofthe promoter site, can be used to physically block RNA polymerase fromtraveling down the strand of the DNA and producing mRNA duringtranscription. Ribosomes translate mRNA into proteins duringtranslation, which occurs after transcription. Since a repressor proteinprevents production of the mRNA during transcription, a particularprotein may not be produced during translation.

FIG. 2C provides an example of a method of preparing a cloned biologicalmaterial (i.e., a shaped tissue structure or a shaped organ structure)from a tissue or an organ, further including genetically modifying cellsto express or inactivate the expression of a protein, an enzyme, or afactor for prevention or reduction of thrombosis, hyperplasia,inflammation, occlusion, and immunological reactions. In step 201 c ofFIG. 2C, cellular material may be removed from fetal neonatal foreskin.The cellular material may be isolated from the fetal neonatal foreskinin step 202 c. The cellular material may be treated with digestiveenzymes to disaggregate the cellular material from the fetal neonatalforeskin in step 202 c. The cellular material is dissociated into a cellsuspension in step 203 c and cell separation is used to obtain desiredcells in step 204 c. Optionally, the cells may be genetically modifiedto produce anti-coagulation products in step 205 c. The desired cellsare inoculated and grown on a shaped matrix in steps 206 c and 207 c. Asthe desired cells grow on the shaped matrix, a shape tissue structure isformed in step 207 c. The shaped tissue structure is used on anon-living medical device or as part of a non-living medical device forproving treatment, diagnosis, cure, mitigation and prevention ofdisease, injury, handicap or condition in a living organism in step 208c.

FIG. 3 provides an example of a method of dissociating the cellularmaterial into a cell suspension using cell separation to obtain desiredcells, wherein cell separation is cloning and cell selection. Inaccordance with step 301 of FIG. 3, connective tissue such as cartilage(i.e., articular cartilage, auricular cartilage, costal cartilage,elastic cartilage, fibrous cartilage, hyaline cartilage, meniscalcartilage and yellow cartilage) may be excised from an individual, whowill receive a non-living medical device or a part of a non-livingmedical device. The cellular material may be isolated from cartilage instep 302. Articular chronodrocytes may be isolated from the articularcartilage, a connective tissue comprising chondrocytes in theextracellular matrix. Articular cartilage is located on the articularsurfaces of the bone in an individual. The cartilage may bedisaggregated and treated with digestive enzymes (i.e., trysin,chymotrysin, collagenase, elastase, hydraluronidase, DNase, pronase,disease) and/or chelating agents such as trysin in step 304. Thecellular material is dissociated in a cell suspension in step 304. Then,the desired cells (i.e., articular chronodrocytes) are obtained from thedissociated piece of cartilage using cloning and cell election in step305. The desired cells may be genetically modified to express enzymes orfactors for prevention or reduction of thrombosis, hyperplasia,inflammation, occlusion or other immune reactions in step 306. Thedesired cells are distributed as a suspension on a shaped matrix in step307. The shapes of the matrix may be tubular, thread-like, twisted,flat, spherical, rod-like or cubical. Those of ordinary skill in the artwill know how to modify the shape of matrix without departing from thespirit of the invention. The desired cells are grown on the shapedmatrix to form a shaped tissue structure in step 308. The clonedbiological material (i.e., shaped tissue structure) is used on anon-living medical device or as part of the non-living medical devicefor proving treatment, diagnosis, cure, mitigation and prevention ofdisease, injury, handicap or condition in a living organism in step 309.

The shaped matrix may comprise porous material, non-porous material,biodegradable material (e.g., polyglycolic acid, collagen,polyorthoesters, polycaprolactones, collagen sponge, woven collagen,gelatin, polylactic acid, polyglycolic acid) and/or non-biodegradablematerial (e.g., polyamides, polyesters, polyesteramide, polystrene,fluorinated ethylene propylene, polypropylene, polyacrylates, polyvinyl,polycarbonate, polytetrafluoroethylene, polyethylene, polyethyleneterapthalate, silicone, silicone rubber, polysulfone, thermanox,polyurethane, polyacrylics, polyhydroxymethyacrylates, nitrocellulose,cotton).

The method of using a cloned biological material (i.e., a shaped tissuestructure or shaped organ structure) on a non-living medical device oras part of a non-living medical device may include modifying or refiningthe cloned biological material (i.e., shaped tissue structure or shapedorgan structure). Once the cells derived from tissue or organs areinoculated and grown on the matrix, then the cell may be grown to formcloned biological materials of various shapes (i.e., shaped tissuestructures or shaped organ structures of various shapes, includingtubular structures, thread-like structures, twisted rope structures,flat structures, sheet structures, spherical structures, rod structures,cubical structures, and/or other shaped structures.) For example, bloodvessels may be constructed from tubular structures. The clonedbiological materials (i.e., shaped tissue structures or shaped organstructures) may also be of various thicknesses. The dimensions of thecloned biological material (i.e., shaped tissue structure or shapedorgan structure) may be modified or refined using medical instruments,including but not limited to lasers, surgical scissors and scalpels.FIG. 4 illustrates a method of using a cloned biological material (i.e.,a shaped tissue structure or a shaped organ structure) on a non-livingmedical device or as part of a non-living medical device, includingmodifying or refining the shaped tissue structure or shaped organstructure.

The method of using a cloned biological material (i.e., a shaped tissuestructure or a shaped organ structure) on a non-living medical device oras a part of the non-living medical device may include attaching thecloned biological material on the non-living medical device or as a partof the non-living medical device. FIG. 5 illustrates a method of using acloned biological material (i.e., a shaped tissue structure or shapedorgan structure) on a non-living medical device or as part of anon-living medical device may include attaching the shaped clonedbiological material on a non-living medical device or as a part of thenon-living medical device. The cloned biological material (i.e., shapedtissue structure or shaped organ structure) is attached on a non-livingmedical device or attached as a part of the non-living medical devicevia attachment methods known to those skilled in the art (i.e., surgicalneedle, adhesive bonding, bonding agent, pins).

The cloned biological materials (i.e., shaped tissue structures orshaped organ structures) may be used on a non-living medical devices,including, but are not limited to medical machines, pacemakers,pacemaker electrodes, mechanical heart valves, endocardial leads,artificial heart valves, cardiac assistance devices, implantable cardiacstimulation devices, implantable pacemaker cardioverter defibrillator(ICD), cardiac rhythm management device, coronary shunts, cerebrospinalfluid shunts, dialysis machines, catheters, dialysis catheters,prosthesis, vascular implants, aortic implants, tissue implants,cardiovascular implants, drug delivery devices, medical delivery pumps,effectors, hemostasis valves, annuloplasty devices such as bands orrings, which are placed around the annulus of the mitral valve todecrease the risk of annular dilation and tension of the suture.

The non-living medical device may comprise a first component such as amatrix or non-biological material, including carbon, carbon polymers,inorganic fibers, nanofibers, amorphous carbon, pyrolytic carbon,vitreous carbon and glassy carbon), wood, cellulose, fibrin, elastin,porcine, human biological members e.g., cellular material, tissue, organand proteins, metals e.g., platinum, iridium, tantalum, and titanium,alloys, aluminum oxide, silicone elastomer, rubber, polymer, polylysine,polyglycolic acid, polyamide, polyolefin, polyester, poly-paradioxane,polycarbonate, polyether, polyvinyl chloride, polyurethane, polystyrene,polyacrylate polyethylene, polypropylene, polytetrafluoroethylene or acombination thereof. A cloned biological material (i.e., shaped tissuestructure or shaped organ structure) may be attached to a secondcomponent on the non-living medical device. The first component and thesecond component may be operatively attached for providing treatment,diagnosis, cure, mitigation and prevention of disease, injury, handicapor condition in a living organism.

The cloned biological materials (i.e., shaped tissue structures orshaped organ structures) may be used on a non-living medical devicescomprising a first component such as a matrix or non-biological materialof alloys including, but are not limited to titanium alloys, iridiumalloys, magnesium alloys, copper alloys, platinum alloys, molybdeniumalloys, stainless steel, (e.g. 316L), nickel alloys, nickel-titaniumalloys, tantalum alloys, cobalt-iron alloys, chromium cobalt alloys(e.g. Elgiloy), chromium cobalt-nickel alloys, chromium cobalt-nickelmolybdenium alloys. The cloned biological materials (i.e., shaped tissuestructures or shaped organ structures) may be used on non-living medicaldevices comprising a first component of platinum alloys including, butare not limited to platinum-iridium. The cloned biological materials(i.e., shaped tissue structures or shaped organ structures) may be usedon a non-living medical device comprising a first component of chromiumcobalt-nickel molybdenium alloys including, but are not limited to MP35N, which is the trademark for a chromium cobalt-nickel molybdeniumalloy, consisting of 35% cobalt, 35% nickel, 20% chromium and 10%molybdenium and MP20N, which is the trademark for a chromiumcobalt-nickel molybdenium alloy, consisting of 50% cobalt, 20% nickel,20% chromium and 10% molybdenium.

FIG. 6 illustrates a medical device comprising a first component havingnon-biological material and second component having cloned biologicalmaterial attached and operatively associated in a non-living medicaldevice for treatment, diagnosis, cure, mitigation and prevention ofdisease, injury, handicap or condition in a living organism.

A cloned biological material (a shaped tissue structure or a shapedorgan structure) may be used on a non-living medical device or as partof a non-living medical device (i.e., tube, bolt, screw, and gasket). Inone aspect of the present invention, the cloned biological material(i.e., shaped tissue structure or shaped organ structure) is a secondcomponent grown from cloned cells may be used as an enclosure (i.e.,covering or casing) on a catheter for preventing or reducingimmunological reactions when the catheter is inserted into a patient.FIG. 7 illustrates a cloned biological material such as a shaped tissuestructure is a second component grown from cloned cells used as anenclosure of a catheter for preventing immunological reaction. FIG. 7shows a catheter, including a distal cap 701, mapping electrodes 702,704, a base stem 703, insulating sleeve 706 and base electrode 705. InFIG. 7, the shaped tissue structure enclosure 707 surrounds the distalcap 701 of the catheter, the mapping electrode 702, 704, base electrode705 and insulating sleeve 706.

A cloned biological material (i.e., a shaped tissue structure or ashaped organ structure) may be used as a dialysis catheter enclosure fora nonliving medical device such as a dialysis medical machine or a part(i.e., a dialysis tube) on a dialysis medical machine (i.e., kidneydialysis machine). In accordance with FIG. 8, cloned biological material(i.e., shaped tissue structures or shaped organ structures) may be as asecond component in the form of tube on a non-living medical device suchas a dialysis medical machine. FIG. 8 and FIG. 8A show simplifiedexamples of cloned biological materials (i.e., shaped tissue structuresor shaped organ structures) as a second component in the form of adialysis venous tube 806 and cloned biological materials in the form ofa dialysis arterial tube 807 for a dialysis medical machine 801, FIG. 8Billustrates examples of cloned biological materials (i.e., shaped tissuestructures or shaped organ structures in the form of connector tubes ofa dialysis medical machine.

In accordance with FIG. 8 and FIG. 8A, the dialysis medical machine 801may include a rotator 821, a pump 834 and a pump head 822 for pumpingblood from a dialysis patient 804 through a dialysis arterial tube 807to an arterial cavity 820 and pumping blood from an arterial cavity 820to chamber 835. The dialysis arterial tube 807 receives blood from adialysis patient and transports blood to an arterial cavity 820. Thearterial cavity 820 receives blood through the dialysis arterial tube807. An arterial tubing fastener 808 prevents the flow of blood from thedialysis patient through the dialysis arterial tube 807 to the arterialcavity 820.

A dialysis sterilizer 810 sterilizes blood that is transported to thedialysis sterilizer 810. A cloned biological material (i.e., a shapedtissue structure or shaped organ structure) as a second component in theform of first connector tube 830 transports blood through a blood port829 of the dialysis sterilizer 810. A first cavity 836 of the dialysissterilizer 810 receives blood from the blood port 829. A dialysissolution pump 841 transports a dialysis solution 839 from a dialysissolution source 842 through a dialysis solution tube 840. The dialysissolution 839 is further pumped through a dialysis port 823 to a secondcavity 838. A sterilizer filter 837 filters waste from the blood. Thesecond cavity 838 receives the waste that will be added to the dialysissolution 839 in the second cavity 838. A blood duct 818 receivessterilized blood from the dialysis sterilizer 810. A cloned biologicalmaterial (i.e., a shaped tissue structure or a shaped organ structure)in the form of second connector tube 817 transports sterilized bloodfrom the blood duct 818 to a venous cavity 819.

The venous cavity 819 receives sterilized blood transported from theblood duct 818 via the second connector tube 817 to a venous port 832 ofthe venous cavity 819. A cloned biological material (i.e., a shapedtissue structure or shaped organ structure) in the form of venous cavitytube 825 receives the sterilized blood from the venous cavity 819. Abubble indicator 805 expels air in the sterilized blood. The sterilizedblood leaves the venous cavity 819 through a venous duct 833. A venoustubing fastener 809 clamps the dialysis venous tube 806 and prevents thetransport of air from the venous cavity 819 through the dialysis venoustube 806 when the bubble indicator 805 detects air in the sterilizedblood. The dialysis venous tube 806 transports sterilized blood to thedialysis patient.

After the sterilizer filter 837 filters waste from the blood, the secondcavity 838 receives the waste, and the waste is added to the dialysissolution 839 in the second cavity 838, the waste dialysis solution 846of FIG. 8B is transported through waste duct 831 of the second cavity838. A waste dialysis solution pump 844 is used to pump the wastedialysis solution 846 through a waste tube 843 into a waste container845.

The dialysis medical machine 801 may also include a stand 814 forholding the saline bag 828. Saline 827 in a saline bag 828 may betransported through a saline tube 826 and may be used to return anyremaining blood in the arterial cavity 820 to the dialysis patient. Thedialysis medical machine 801 may include a syringe 811 and syringe tubefor delivering heparin to the chamber 835 to reduce or preventingcoagulation of the blood. The dialysis medical machine may also includea covering 812 and a covering 815. The dialysis medical machine 801 mayinclude a touch sensitive screen 816 for inputting and outputtinginformation.

FIG. 9 illustrates a cloned biological material (i.e., a shaped tissuestructure) grown from cloned cells used as a second component (i.e., atube) on an annuloplasty band for preventing the deleterious effectsfrom bodily contact with foreign or artificial material of theannuloplasty band. FIG. 9 shows wires 901, a sheath 902, tube 903 and asuture 904 of an annuloplasty band. Wires 901 of an annuloplasty bandmay be comprised of copper. The wires may be insulated by a sheath 902and/or tube 903. The tube 903 may be comprised of a shaped tissuestructure, derived from cloned cellular material that is compatible withthe patient receiving the annuloplasty band.

A cloned biological material (i.e., a shaped tissue structure or ashaped organ structure) may be used as a part (i.e., a tube) on anon-living medical device such as a drug delivery device. FIG. 10illustrates an example of a cloned biological material (i.e., a shapedtissue structure) from cloned cells used as a drug delivery tube for adrug delivery device for providing treatment, diagnosis, cure,mitigation and prevention of diseases, injury handicap or condition in aliving organism. FIG. 10 shows an intravenous container 1004 and amicrochip device 1006. A substrate 1010 may have at least one areservoir 1007. A seal 1011 seals base of the reservoir 1007. Areservoir 1007 contains drug molecules 1008 for release. A reservoir top1009 covers the reservoir 1007 containing the drug molecules 1008. Thereservoir top 1009 is selectively permeable to the drug molecules 1008in the reservoir 1007. Thus, the drug molecules 1008 may be releasedfrom the reservoir top 1009 of the reservoir 1007 and mixed with a fluid1001 of a chamber 1002. The fluid 1001 of the chamber 1002 may befurther mixed with drugs molecules 1008 using a mixer 1003. The mixture1012 of fluid 1001 and drug molecules 1008 passes through theintravenous container 1004. Then, the mixture 1012 flows through a drugdelivery tube 1005 intravenously to a patient. FIG. 10A illustrates asimplified example of a microchip device 1006, including a substrate1010, a reservoir 1007, drug molecules 1008 for release, a reservoir top1009 and a seal 1011.

FIG. 11 illustrates a cloned biological material (i.e. a shaped tissueor organ structure) in the form of a screw 1116 in a non-living medicaldevice such as an end effector 1100 of a robotic surgical arm 1106. Theend effector 1100 may include a surgical device 1103, comprising finger1101, finger 1102, a surgical rod 1103 and a surgical sleeve 1104. Thesurgical device 1103 may be connected to a driver 1115. The driver 1115includes a cylinder 1113 and a driver cell 1117. A transmission gearenclosure 1119 is connected to a reverse gear motor 1120. The driver1115 may be attached to a nut 1118. The nut 1118 may be attached to acloned biological material (i.e., a shaped tissue structure or a shapedorgan structure) as a second component formed into a screw 1116. The endeffector 1100 may be mounted on a robotic surgical arm 1106 using aconnector assembly 1108, including a collar 1121, a holder 1110 and amotor gear device 1107. The holder 1110 includes a shaft 905. The motorgear device 1107 is powered by a motor in the connector assembly 1108 ofthe robotic surgical arm 1106. The motor gear device 1107 causes thecollar 1121 to rotate. In turn, the surgical device 1103 rotates. A pin1112 may be received by an aperture 1111 of the driver 1115. When theaperture 1111 of the driver 1115 receives the pin 1112, the decouplingdevice 1109 is secured to the driver 1115. The decoupling device 1109may be used to disconnect the surgical device 1103 from the driver 1115.

FIG. 12 and FIG. 12A illustrate examples of a cloned biological material(i.e., a shaped tissue structure or a organ structure) grown from clonedcells in the form of a bolt on a non-living medical device or medicalmachine such as an medical delivery pump for delivering drugs to apatient. The cloned biological material in the form of a bolt may besecond component of the nonliving medical device. In FIG. 12 illustratesan example of an medical delivery pump 1201, including a bolt 1202,comprised of a cloned biological material (i.e., a shaped tissuestructure or organ structure) grown from cloned cells. The medicaldelivery pump 1201 may include a bottom support covering 1203, areceptacle 1204, arms 1205, 1206, 1207 and 1208, fluid vessel 1209, line1210, plate 1211, slide 1212, spring 1213, guide 1214 and handle 1215,top support covering 1216. FIG. 12A illustrates a medical delivery pump1201 with a depressed receptacle 1204. The receptacle 1204 may bedepressed as the handle 1215 is turned to disengage the handle 1215 fromthe bolt 1202 causing the plate 1211 to descend toward the bottomsupport covering 1203.

FIG. 13 illustrates an example of a cloned biological material (i.e., ashaped tissue structure or a shaped organ structure) as a secondcomponent in the form of a gasket 1305. FIG. 13A shows a hemostasisassembly 1300 comprising a sheath 1301, a housing 1302, a hemostasisport 1303, a hemostasis valve 1306 and a hemostasis top 1307. The sheath1301 may be a tubular shaped tissue or tubular organ structure formedfrom cloned biological material. The hemostasis valve 1306 may include agasket enclosure 1304 and a cloned biological material (i.e. shapedtissue or organ structure) in the form of a gasket 1305. The gasket 1306may include an aperture 1310 and slit 1311 for receiving a catheter. Theprojecting part 1309 of the gasket enclosure 1304 may be slid over thenotch 1308 of the gasket 1305 to secure the gasket enclosure 1304 to thegasket 1305. The hemostasis valve 1306 may be positioned inside thehousing 1302. The hemostasis top 1307 may be attached, adhered, fused,compressed or threaded to the housing 1302.

In another aspect, the present invention provides a cloned biologicalmaterial (i.e., a shaped tissue structure or a shaped organ structure)grown from cloned cells for use on a cardiac assist device for creatingor improving medical machines or non-living medical devices andpreventing immunological reactions such as compliment activation. FIG.14 illustrates a cloned biological material such as a shaped tissuestructure grown from cloned cells for use on a pacemaker for treatment,diagnosis, cure, mitigation and prevention of disease, injury, handicapor condition in a living organism. A non-living medical device mayinclude a cardiac assist device. A cardiac assist device such as apacemaker determines whether the heart is beating at an abnormal cardiacrhythm. The pacemaker responds by returning the heart to the normalcardiac rhythm. The pacemaker provides electrical stimulation to theatrium or ventricle of the heart by delivering pacing pulses to thechamber of the heart. Alternatively, the pacemaker may provide dualheart chamber electrical stimulation to the atrium and ventricle.

The pacemaker is subcutaneously implanted into the heart. The pacemakerincludes one or more leads 1402 (i.e., unipolar lead, bipolar lead),extending from the pacemaker, for implantation into the heart. The leads1402 may include a right ventricular lead and/or an atrial lead. Thepacemaker may include an amplifier 1408 for determining whether a signalexceeds a specified threshold. The lead 1402 stimulates electricalpacing pulses and senses electrical signals from the at particularsites. For example, the pacemaker may be connected to the patient viathe right ventricular lead. The right ventricular lead monitors theconditions and indicators of the right ventricular and stimulateselectrical pulses to the right ventricular.

The leads 1402 comprise electrodes, positioned close to the chamber ofthe heart. The electrodes 801 may be one of a ring electrode, a tipelectrode, coil electrode and/or combination thereof. The electrodes1401 of the lead sense the rhythmical cardiac activity, physiologicalconditions and electrical cardiac functions.

Each electrode 1401 (i.e., ring electrode, a tip electrode, coilelectrode) is connected to the circuitry 1414 (i.e., electricalconductor), which is located within the lead body. A connector blockreceives a connector, which may be located at the proximal end of theventricular lead. The connector block is attached to a housing.

The lead comprises a lead body. Within the lead body is the circuitry1414 of the pacemaker. A housing 1403 (i.e., metal encasing,hermetically sealed enclosure, case) holds a controller 1415 therein.The housing 1403 may be encased within an outer sheath 1404 thatelectrically insulates the circuitry 1414 of the housing. Alternatively,the outer sheath 1404 may encase the housing 1403 and lead 1402.Further, a cloned biological material (i.e., a shaped tissue structure)1406, surround the outer sheath 1404 of the pacemaker to protect thebody from immunological reactions to the outer sheath 1404 and preventthe compliment activation of blood such as the creation of microembolithat may occur from contact with outer sheath 1404 of the pacemaker. Thecloned biological material (i.e., shaped tissue structure) 1406 may begrown from cloned cells.

The memory of the controller 1415 includes a read-only memory (ROM) 1411and random-access memory (RAM) 1412. The controller (i.e.,microprocessor) is linked to the memory through a bus. The read-onlymemory (ROM) 1411 of the controller 1415 stores programs for operationof the controller 1415. The controller 1415 may be programmed through anexternal programming device 1416, which is not located in the housing1403 of the pacemaker. The random-access memory (RAM) 1412 stores datasuch as measurements of impedance. The controller 1415 processes digitalsignals. The controller 1415 stores the digital signals in the randomaccess memory (RAM) 1412. The controller 1415 also controls the deliveryof pacing pulses. The housing 1403 of the pacemaker may include a switch1413 for operating the controller 1415. When a lead 1402 senses that theheart beat rate of a bradycardia patient is below the lower rate limit(LRL), electrical pacing pulses are delivered to the bradycardiapatient. The controller 1415 may be interfaced with a telemetry system1410 for communicating telemetry to a programmer. The programmerincludes a display device, printer output device and/or combinationthereof.

The present invention provides for creating or improving medicalmachines or non-living medical devices from the interfacing of at leasttwo different materials selected from the group consisting of a shapedtissue structure, a shaped organ structure, a biological member. Thecircuitry of the non-living medical device is created from theelectronic potential that results when different material areinterfaced.

The method for reducing or preventing immune reactions and creating orimproving medical machines or non-living medical devices, said method,further comprising: creating each and every part of said non-livingmedical device from at least one of a first group consisting of saidshaped tissue structure, said shaped organ structure, and a combinationthereof, and at least one of a second group consisting of a biologicalmember and a combination thereof.

The biological member includes, but is not limited to an atom, amolecule, an enzyme, a protein, a cell, a bone, a tendon, a ligament, avessel, a muscle, a joint, an artery, a vein, a nerve, a tissue and anorgan.

In another aspect, the method of preparing a shaped tissue structure ora shaped organ structure from a tissue or an organ includes removing aportion of a tissue or an organ from an individual; isolating a cellularmaterial from the portion of the tissue or the organ; dissociating thecellular material into a cell suspension using cell separation to obtaindesired cells, and growing the desired cells on said non-living medicaldevice to form the cloned biological material (i.e., shaped tissuestructure or the shaped organ structure). FIG. 15 illustrates a methodof preparing a cloned biological material (i.e., shaped tissue structureor a shaped organ structure) from a tissue or an organ includes growingthe desired cells on said non-living medical device to form the shape ofa biological cloned material in step 1508.

What is claimed is:
 1. A method comprising: preparing a clonedbiological material from a tissue or an organ; attaching said biologicalmaterial to a non-living medical device; interfacing said biologicalmaterial with the non-biological material; and providing treatment,diagnosis, cure, mitigation and prevention of disease, injury, handicapor condition in a living organism.
 2. The method of claim 1, saidpreparing said a cloned biological material from said tissue or saidorgan includes removing a portion of said tissue or said organ from anindividual; isolating a cellular material from said portion of saidtissue or said organ; dissociating said cellular material into a cellsuspension using cell separation to obtain desired cells; and growingthe desired cells on a shaped matrix to form said cloned biologicalmaterial.
 3. The method of claim 2, said removing said portion of saidtissue or said organ from said individual includes excising said portionof said tissue or said organ.
 4. The method of claim 2, said isolatingsaid cellular material from said portion of said tissue or said organincludes disaggregating said cellular material from said tissue with adigestive enzyme.
 5. The method of claim 4, said disaggregating saidcellular material from said tissue with a digestive enzyme selected froma group consisting of: trysin, chymotrysin, collagenase, elastase,hydraluronidase, DNase, pronase, and dispase.
 6. The method of claim 2,said isolating said cellular material from said portion of said tissueor said organ includes treating said tissue or said organ with achelating agent.
 7. The method of claim 1, wherein said tissue is aconnective tissue.
 8. The method of claim 2, wherein said desired cellsare selected from a group consisting of: pericytes, adipoctyes,macrophages, monocytes, plasma cells, mast cells, and endothelial cells.9. The method of claim 1, wherein said tissue is selected from a groupconsisting of: articular cartilage, auricular cartilage, costalcartilage, elastic cartilage, fibrous cartilage, hyaline cartilage,meniscal cartilage, and yellow cartilage.
 10. The method of claim 2,wherein said desired cells are articular chronodrocytes from articularcartilage.
 11. The method of claim 1, wherein said tissue is fetalneonatal foreskin.
 12. The method of claim 2, said dissociating saidcellular material into said cell suspension using said cell separationto obtain said desired cells, wherein said cell separation is selectedfrom the group consisting of negative separation, filtration,centrifugation, electrophoresis, unit gravity separation, cloning andcell selection, or a combination thereof.
 13. The method of claim 2,wherein said shaped matrix is least one of a tubular structure, athread-like structure, a twisted rope structure, a flat structure, asheet structure, a spherical structure, a rod structure, a cubicalstructure or a combination thereof.
 14. The method of claim 1, furthercomprising genetically modifying said desired cell to express orinactivate the expression of a protein, an enzyme, or a factor forprevention or reduction of one of at least one of thrombosis,hyperplasia, inflammation, occlusion, immunological reactions and acombination thereof.
 15. The method of claim 1, said preparing saidcloned biological material includes removing said portion of said tissueor said organ from a donor.
 16. The method of claim 1, furthercomprising genetically modifying said desired cell to produce ananticoagulation product.
 17. The method of claim 2, wherein said shapedmatrix comprises at least one of a group consisting of: a porousmaterial, non-porous material, biodegradable material, non-biodegradablematerial biodegradable material, and a combination thereof.
 18. Themethod of claim 2, wherein said biodegradable material is selected fromthe group consisting of a polyglycolic acid, a collagen, apolyorthoester, a polycaprolactone, a collagen sponge, a woven collagen,a gelatin, a polylactic acid, a polyglycolic acid, and combinationthereof.
 19. The method of claim 2, wherein said non-biodegradablematerial is selected from a group consisting of: a polyamide, apolyester, a polyesteramide, a polystrene, a fluorinated ethylenepropylene, a polypropylene, a polyacrylate, polyvinyl, a polycarbonate,a polytetrafluoroethylene, a polyethylene, a polyethylene terapthalate,a silicone, a silicone rubber, a polysulfone, a thermanox, apolyurethane, a polyacrylics, a polyhydroxymethyacrylate, anitrocellulose, and a cotton.
 20. The method of claim 1, said using saidcloned biological material on said non-living medical device or as saidpart of said medical device includes modifying or refining a shape ofsaid cloned biological material.
 21. The method of claim 1, said usingsaid shaped tissue structure or said shaped organ structure on saidmedical device or as said part of said medical device includes attachingsaid shaped tissue structure or said organ structure on said medicaldevice or as said part of said medical device.
 22. The method of claim2, wherein said medical device is selected from a group consisted of: apacemaker, a pacemaker electrode, a mechanical heart valve, anendocardial leads, an artificial heart valve, a cardiac assistancedevice, an implantable cardiac stimulation device, an implantablepacemaker cardioverter defibrillator (ICD), a cardiac rhythm managementdevice, a coronary shunt, a cerebrospinal fluid shunt, a dialysismachine, catheter, a prosthesis, a vascular implant, an aortic implant,a tissue implant, a cardiovascular implant, an annuloplasty device, adrug delivery device, a medical delivery pump, an effector, and ahemostasis valve.
 23. The method of claim 1, wherein said medical deviceis comprised of at least two materials selected from a group consistingof: a shaped tissue structure, a shaped organ structure, and abiological member.
 24. The method of claim 1, wherein said medicaldevice is comprised of at least two different materials selected from agroup consisting of: a shaped tissue structure, a shaped organstructure, a biological member, and a carbon, a carbon polymer, aninorganic fiber, a nanofiber, an amorphous carbon, a pyrolytic carbon, avitreous carbon, a glassy carbon, a metal, an alloy, a siliconeelastomer, a rubber, a polymer, a polylysine, a polyglycolic acid, apolyamide, a polyolefin, a polyester, a polyparadioxane, apolycarbonate, a polyether, a polyvinyl chloride, a polyurethane, apolystyrene, a polyacrylate polyethylene, a polypropylene, and apolytetrafluoroethylene.
 25. The method of claim 1, wherein saidnon-living medical device is a catheter.
 26. The method of claim 2,wherein said using said cloned biological material as an enclosure on acatheter.
 27. The method of claim 1, wherein said cloned biologicalmaterial is a tube, a gasket, bolt or screw.
 28. The method of claim 1,wherein said medical device is a dialysis medical machine and whereinsaid tube is a dialysis tube.
 29. The method of claim 1, wherein saidmedical device is an annuloplasty band and wherein said tube is anannuloplasty tubing.
 30. The method of claim 1, said method, furthercomprising: creating each and every part of said medical device from atleast one of a first group consisting of said shaped tissue structure,said shaped organ structure, and a combination thereof, and at least oneof a second group consisting of a biological member and a combinationthereof.
 31. The method of claim 30, wherein said biological member isselected from the group consisting of: an atom, a molecule, an enzyme, aprotein, a cell, a bone, a tendon, a ligament, a vessel, a muscle, ajoint, an artery, a vein, a nerve, and a tissue and an organ.